Non-Interventional Post-Authorization Safety Study on the Long-Term Safety of HyQvia in Subjects Treated with HyQvia (161302)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, uncontrolled, multi-center, open-label, Post-Authorization Safety Study (PASS)

Study drug and medical condition

• Name of medicine:
  HYQVIA
• Study drug International non-proprietary name (INN) or common name:
  HYALURONIDASE (HUMAN RECOMBINANT)
• Medical condition to be studied:
  Primary immunodeficiency syndrome

  Chronic lymphocytic leukaemia

  Plasma cell myeloma

Population studied

• Short description of the study population:
  Adult patients (≥18 years) who were prescribed treatment with HyQvia were enrolled in the EEA.; ; Subjects who met ALL of the following criteria were eligible for this study:; 1. Subject required IG treatment; 2. Subject was ≥18 years old at the time of screening; 3. Subject had been prescribed treatment with HyQvia prior to enrollment; 4. Subject was willing and able to comply with the requirements of the protocol; ; Subjects who met ANY of the following criteria were not eligible for this study:; 1. Subject had known hypersensitivity to any of the components of the medicinal product; 2. Subject had participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment, or was scheduled to participate in an interventional clinical study involving a medicinal product or device during the course of the study; 3. Subject was a family member or employee of the investigator
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  111

Study design details

• Main study objective:
  Long-term safety of HyQvia treatment in subjects receiving treatment with HyQvia
• Outcomes:
  Incidence of all related serious adverse events (SAEs), Incidence of: - all SAEs and non-SAEs - immunologic AEs - temporally and/or causally associated systemic allergic AEs - new onset of other AEs that are potentially immunologically mediated - gastrointestinal symptoms - and titer of antibodies to rHuPH20, and other labs (if available) Dose Infusion interval Health-related quality of life and health resource use assessments
• Data analysis plan:
  Statistical analyses and data displays will be mainly descriptive. Data from all enrolled subjects will be included in the analysis. If groups of sufficient sample size (such as: age groups, PIDD types) are available, confidence intervals may accompany the point estimates. All SAEs and non-serious AEs will be categorized according to MedDRA system organ class (SOC) and preferred term.